Early Bird Wintergreen and Peppermint
- Product NDC
- 72164-001
- Requested package NDC
- 72164-001-01
- 11-digit product format
- 721640001
- Labeler code
- 72164
- Product ID
- 72164-001_ebe7cc38-e054-1d14-e053-2a95a90aad8f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- POTASSIUM NITRATE, SODIUM FLUORIDE
- Dosage form
- PASTE
- Route
- DENTAL
- Labeler
- Smiletwice, Inc.
- Application
- part356
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 2018-05-18
- Marketing end
- 0000-00-00
- Substance
- POTASSIUM NITRATE; SODIUM FLUORIDE
- Active strength
- 50 mg/g; mg/g
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 72164-001 | 72164-001-01 | I | Inactivated by FDA | 2026-10-05 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| 6084a4f4-5437-c9a5-caec-5361ee075a59 | Product name | 1 | 20140508 |
| 90c5639a-61b0-88d6-ddcf-21888e94869a | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 72164-001-00 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-9d1e-d83d-e063-dadaa90ab31f | Early Bird Wintergreen and Peppermint Toothpaste |
| 72164-001-01 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-9d1e-d83d-e063-dadaa90ab31f | Early Bird Wintergreen and Peppermint Toothpaste |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72164-001-00 | Early Bird Wintergreen and Peppermint | 96 g in 1 TUBE | PASTE | 96 | 6 | |
| 72164-001-00 | Early Bird Wintergreen and Peppermint | 2 in 1 BOX | PASTE | 2 | 6 | |
| 72164-001-01 | The Duo | 96 g in 1 TUBE | PASTE | 96 g | 50 mg in 1g | 6 |
| 72164-001-01 | 4 Pack | 96 g in 1 TUBE | PASTE | 192 g | 50 mg in 1g | 6 |
| 72164-001-01 | Early Bird Wintergreen and Peppermint | 96 g in 1 TUBE | PASTE | 96 | 6 | |
| 72164-001-02 | Mini Duo | 23 g in 1 TUBE | PASTE | 23 g | 50 mg in 1g | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 72164-001 | 4 PACK (POTASSIUM NITRATE, SODIUM FLUORIDE) KIT [SMILETWICE, INC.] | 6 | Legacy NDC | 20231221_c3707c03-3761-4901-89c4-11d214c9287d.zip |
| 72164-001 | EARLY BIRD WINTERGREEN AND PEPPERMINT (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE [SMILETWICE, INC.] | 6 | Legacy NDC, 3 package rows | 20221027_10743960-2a60-4a2f-a024-8e3b79b0d118.zip |
| 72164-001 | THE DUO (POTASSIUM NITRATE, SODIUM FLUORIDE) KIT [SMILETWICE, INC.] | 6 | Legacy NDC | 20231221_4c10df9f-cc42-41ba-968e-0f4470536e3d.zip |
| 72164-001 | MINI DUO (POTASSIUM NITRATE, SODIUM FLUORIDE) KIT [SMILETWICE, INC.] | 3 | Legacy NDC | 20231221_99509d36-cae4-43a7-9ae7-74c101b1bee9.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1038929 | potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste | PSN | 10743960-2a60-4a2f-a024-8e3b79b0d118 | 6 |
| 1038929 | potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste | PSN | 4c10df9f-cc42-41ba-968e-0f4470536e3d | 6 |
| 1038929 | potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste | PSN | c3707c03-3761-4901-89c4-11d214c9287d | 6 |
| 1038929 | potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG Toothpaste | SCD | 10743960-2a60-4a2f-a024-8e3b79b0d118 | 6 |
| 1038929 | potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG Toothpaste | SCD | 4c10df9f-cc42-41ba-968e-0f4470536e3d | 6 |
| 1038929 | potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG Toothpaste | SCD | c3707c03-3761-4901-89c4-11d214c9287d | 6 |
| 1038929 | K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste | SY | c3707c03-3761-4901-89c4-11d214c9287d | 6 |
| 1038929 | K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste | SY | 10743960-2a60-4a2f-a024-8e3b79b0d118 | 6 |
| 1038929 | K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste | SY | 4c10df9f-cc42-41ba-968e-0f4470536e3d | 6 |
| 1038929 | Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste | SY | 10743960-2a60-4a2f-a024-8e3b79b0d118 | 6 |
| 1038929 | Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste | SY | 4c10df9f-cc42-41ba-968e-0f4470536e3d | 6 |
| 1038929 | Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste | SY | c3707c03-3761-4901-89c4-11d214c9287d | 6 |
| 1038929 | potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste | SY | 10743960-2a60-4a2f-a024-8e3b79b0d118 | 6 |
| 1038929 | potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste | SY | c3707c03-3761-4901-89c4-11d214c9287d | 6 |
| 1038929 | potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste | SY | 4c10df9f-cc42-41ba-968e-0f4470536e3d | 6 |
| 1038929 | potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste | SY | 4c10df9f-cc42-41ba-968e-0f4470536e3d | 6 |
| 1038929 | potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste | SY | c3707c03-3761-4901-89c4-11d214c9287d | 6 |
| 1038929 | potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste | SY | 10743960-2a60-4a2f-a024-8e3b79b0d118 | 6 |
| 1038929 | potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste | SY | c3707c03-3761-4901-89c4-11d214c9287d | 6 |
| 1038929 | potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste | SY | 4c10df9f-cc42-41ba-968e-0f4470536e3d | 6 |
| 1038929 | potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste | SY | 10743960-2a60-4a2f-a024-8e3b79b0d118 | 6 |
| 1038929 | potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste | PSN | 99509d36-cae4-43a7-9ae7-74c101b1bee9 | 3 |
| 1038929 | potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG Toothpaste | SCD | 99509d36-cae4-43a7-9ae7-74c101b1bee9 | 3 |
| 1038929 | K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste | SY | 99509d36-cae4-43a7-9ae7-74c101b1bee9 | 3 |
| 1038929 | Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste | SY | 99509d36-cae4-43a7-9ae7-74c101b1bee9 | 3 |
| 1038929 | potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste | SY | 99509d36-cae4-43a7-9ae7-74c101b1bee9 | 3 |
| 1038929 | potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste | SY | 99509d36-cae4-43a7-9ae7-74c101b1bee9 | 3 |
| 1038929 | potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste | SY | 99509d36-cae4-43a7-9ae7-74c101b1bee9 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 72164-001-01 | 72164000101 | 96 g in 1 TUBE (72164-001-01) | 96 g | 2018-05-18 | 0000-00-00 | No | No | Current |